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Bupropion hydrobromide - Generic Drug Details

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What are the generic drug sources for bupropion hydrobromide and what is the scope of bupropion hydrobromide patent protection?

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrobromide has fifty-one patent family members in seventeen countries.

There are thirty-eight drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for bupropion hydrobromide

International Patents:	51
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	38
Suppliers / Packagers:	1
Bulk Api Vendors:	6
Clinical Trials:	327
Patent Applications:	67
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	bupropion hydrobromide at DailyMed

Pharmacology for bupropion hydrobromide

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Synonyms for bupropion hydrobromide

2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one hydrobromide

2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one,hydrobromide

905818-69-1

AK-75761

AKOS015917698

Aplenzin

Aplenzin ER

bupropion HBr

Bupropion hydrobromide (USAN)

Bupropion hydrobromide [USAN]

CHEMBL1201735

D07938

I14-9201

SCHEMBL636116

WSTCENNATOVXKQ-UHFFFAOYSA-N

Tentative approvals for BUPROPION HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
		174MG	TABLET, EXTENDED RELEASE; ORAL
		522MG	TABLET, EXTENDED RELEASE; ORAL

US Patents and Regulatory Information for bupropion hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y

Non-Orange Book US Patents for bupropion hydrobromide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,569,611	Modified release formulations of a bupropion salt
7,579,380	Modified release formulations of a bupropion salt
7,645,901	Modified release formulations of a bupropion salt
7,553,992	Modified release formulations of a bupropion salt

International Patents for bupropion hydrobromide

Country	Document Number	Estimated Expiration
Canada	2655596
South Korea	20100055402
Mexico	2010001449
Russian Federation	2010116863

Supplementary Protection Certificates for bupropion hydrobromide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2017000109	Germany		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2017 00062	Denmark		PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201